GERMANTOWN, Md.—QIAGEN announced Aug. 16 that it has entered into apartnership with Pfizer Inc. for the development of a companion moleculardiagnostic test for use with an investigational Pfizer compound in globalclinical development for treatment of non-small cell lung cancer (NSCLC).Financial terms of the agreement were not disclosed.
Pfizer's investigational compound, dacomitinib (PF-00299804), is an oralinhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (humanepidermal growth factor receptor) signaling pathway plays a role in the complexprocess of cell growth and metastasis, making it a target for anticancer drugs.
QIAGEN's proposed companion diagnostic will be based on its proprietaryKRAS assay technology, which detects mutations of the KRAS gene that arefrequently found in human cancers. Because EGFR inhibitors are generallyeffective in patients without these KRAS mutations, the QIAGEN assay can beuseful in identifying patients most appropriate for EGFR-inhibitor therapies.
QIAGEN recently submitted the application for Premarket Approval (PMA)for KRAS companion diagnostics to the U.S. Food and Drug Administration (FDA)for use with two other, separate drugs targeting metastatic colorectal cancers.
The Pfizer drug companion diagnostic test is being specificallydeveloped for use in lung cancer tissue. It uses the same core assay componentas the therascreen KRAS RGQ kit for colorectal cancers but varies in theworkflow to allow for lung tissue-specific sample technology in a fullyautomated workflow.
The global partnership covers clinical trials and submissions for a PMAapplication in the United States and the CE mark in Europe, as well asapplicable regulatory approvals in other regions.
Following clinical development of the KRAS companion diagnostic forNSCLC, QIAGEN expects to submit a premarket approval application supplement(PMAS) to FDA for full automation of the workflow to allow pathologists easyaccess and processing of lung tissue samples.